Artificial cornea implant aims to reverse blindness in 54-Patient trial
NCT ID NCT07526389
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This clinical trial tests a new artificial cornea (aspheric keratoprosthesis) in 54 adults with severe corneal blindness who cannot have a standard cornea transplant. Participants are randomly assigned to receive either the new device or a control device. The main goal is to see if the implant can restore enough sight to allow independent daily living within 6 months. The study is not yet recruiting and takes place at multiple sites in China.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- artificial cornea implant (aspheric keratoprosthesis)
- What this could lead to
- If successful, this could provide a new option to restore vision in people with severe corneal blindness who cannot have a standard cornea transplant.
- What could go wrong
- This is an early-stage trial with only 54 people, so results may not apply to everyone. The implant carries surgical risks like infection or device failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Apr 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 to 80 years (inclusive), gender unrestricted; 2. Patients with corneal blindness, unable to perform activities of daily living independently, and best-corrected visual acuity \< 0.05 in both eyes; 3. Patients with a high expected risk of failure of allogeneic corneal transplantation or high surgical risk for corneal transplantation; 4. Relatively stable primary ocular diseases, no active purulent infection, and general condition sufficient to tolerate surgery; 5. Normal intraocular pressure, or stable intraocular pressure after treatment for glaucoma (IOP \< 21 mmHg); 6. Normal structure and function of the retina and optic nerve, with preserved visual potential; 7. Willing to participate in this study and have signed the written informed consent form. Exclusion Criteria: 1. Patients with poorly controlled intraocular pressure or requiring IOP-lowering medication, assessed as ineligible for surgery. 2. Patients with active conjunctival infection in the affected eye, assessed as unable to tolerate surgery. 3. Patients with unhealed wound following allogeneic penetrating keratoplasty. 4. Patients with anatomical abnormalities such as eyelid atresia or requiring a prosthetic device to penetrate the skin. 5. Patients with severely impaired retinal or optic nerve function with no potential for visual improvement. 6. Patients with a history of malignant tumor in or around the eye, judged ineligible by the investigator. 7. Patients with intolerance to local anesthetics, mydriatics, or device components, judged ineligible by the investigator. 8. Patients with severe diseases of major organs including heart, liver, and kidney, judged ineligible by the investigator. 9. Patients with severe coagulation disorders, judged ineligible by the investigator. 10. Patients with absolute glaucoma, judged ineligible by the investigator. 11. Patients with severe systemic diseases and a life expectancy of \< 2 years. 12. Pregnant or lactating females. 13. Patients who do not understand the risks of keratoprosthesis surgery, cannot comply with regular follow-up, or fail to administer medication as required. 14. Other patients considered ineligible for this clinical trial by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Corneal blindness are added.
By submitting, you agree to our Terms of use
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.